The FDA has released final guidance on “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products.” One relatively minor difference from the draft version actually represents a major step forward in statistical analyses for randomized controlled trials (RCTs).
Taken as a whole, in one way or another the pieces of this issue are all about not just the need for, but the inevitability of, ongoing change in the clinical research enterprise—not just change for the sake of change, but change for the better.
Principal investigators interviewed for a recent academic dissertation recognized the need for greater diversity among participants in the clinical trials but are frustrated that the inclusion/exclusion criteria handed by sponsors often don’t match the real-life situations of the average patient in their practice with the condition of interest. In the forthcoming August issue of ACRP’s Clinical Researcher journal, these and other findings are detailed in a peer-reviewed article.
To better understand the current site landscape and the top challenges sites are facing, WCG created the 2023 Clinical Research Site Challenges Survey Report, in addition to recommendations for sites, sponsors, and CROs to better address study needs and the needs of the sites conducting those studies.
Untangling the web of regulatory expectations regarding who among sponsors, investigators, and vendors will be held responsible—and when and why—for different key aspects of decentralized clinical trials (DCTs) lies at the crux of comments submitted by the ACRP to the U.S. Food and Drug Administration (FDA) in response to their recent draft guidance on DCTs.